Contact details

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PR-CS011

Study information

Scientific title

A phase II study of GCS-100 in combination with chemo-immunotherapy in relapsed or refractory diffuse large B-cell lymphoma

Acronym

Study hypothesis

The primary objective of this study is to assess the efficacy of GCS-100 with rituximab, ifosfomide, mesna, carboplatin and etoposide (R-ICE) chemotherapy in subjects with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The secondary objective is to determine the safety of GCS-100 in conjunction with cytotoxic chemotherapy.

Ethics approval

The study was approved by the London Research Ethics Committee (REC) of Northwick Park Hospital on the 6th October 2008 (ref: 08/H0718/57)

Study design

Interventional, single-arm, single-centre trial

Primary study design

Interventional

Secondary study design

Single-centre

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Relapsed or refractory diffuse large B-cell lymphoma (DLBCL)

Intervention

This is a single-arm trial of GCS-100 with R-ICE chemotherapy administered in 21-day cycles (a maximum of four chemotherapy cycles per participant). Each 21-day treatment cycle consists of the following:

Intervention type

Drug

Phase

Phase II

Drug names

GCS-100, rituximab, ifosfomide, mesna, carboplatin, etoposide

Primary outcome measures

1. Response: overall response rate, defined as the sum of the number of CR rate and PR rate. CR and PR will be defined according to the International Harmonisation Project for Lymphoma criteria.2. Imaging: CT scans will be obtained at baseline and every two cycles to assess for response. They will be evaluated according to the International Harmonisation Project for Lymphoma.

Total duration of follow-up for the primary and secondary outcome measures: 16 weeks.

Secondary outcome measures

To determine the safety of GCS-100 in conjunction with cytotoxic chemotherapy by collecting adverse event data and monitoring blood parameters, etc. Total duration of follow-up for the primary and secondary outcome measures: 16 weeks.

Overall trial start date

01/12/2008

Overall trial end date

01/12/2009

Reason abandoned

Lack of funding/sponsorship

Eligibility

Participant inclusion criteria

1. Subject is capable of understanding the purpose and risks of the study and is able to provide written informed consent2. Subject is male or female, aged at least 18 years3. Subject has histologically confirmed DLBCL, bidimensionally measurable by computerised tomography (CT) scan, with at least one lesion greater than or equal to 1.5 cm in the greatest diameter. CT scan results must be available prior to dosing to establish eligibility.4. Subject has relapsed or relapsed/refractory disease following at least two cycles of R-ICE chemotherapy as salvage chemotherapy, without partial response (PR) or complete response (CR)5. Subject has greater than or equal to 4 weeks elapsed between last chemotherapy or immunotherapy exposure6. Subject has Eastern Collaborative Oncology Group (ECOG) performance status of 0 or 1

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

14 - 28

Participant exclusion criteria

1. Subject has received high-dose chemotherapy with haematopoietic stem cell support or allogeneic stem cell transplantation (SCT)3. Subject has rapidly progressive lymphoma or lymphoma threatening organ function4. Subjects with primary or secondary central nervous system lymphoma5. Subjects who have had treatment with an experimental (unlicensed) drug within 3 weeks prior to treatment with GCS-1006. Subject has not recovered from all toxic effects of previous chemotherapy, radiation therapy, biologic therapy, and/or experimental therapy7. Subject has a known history of human immunodeficiency virus-related lymphoma, active hepatitis C, active hepatitis B, or prior history of infection with hepatitis B (HBcAb positive) 8. Subject has a clinically relevant active infection and/or a serious co-morbid medical condition such as recent myocardial infarction (within the last 6 months and no electrocardiographic evidence of acute ischaemia or new conduction system abnormalities), unstable angina, difficult-to-control congestive heart failure, uncontrolled hypertension, difficult-to-control cardiac arrhythmias, chronic obstructive or chronic restrictive pulmonary disease, and/or cirrhosis.9. Subject had major surgery within 4 weeks prior to study day 1